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Cara Therapeutics Initiates Phase II Trial of Novel Analgesic In Acute Post-Operative Pain, Shelton, CT, August 3rd, 2011
Cara Therapeutics Announces Appointment of James B. Jones, M.D., Pharm.D., as Chief Medical Officer, Shelton, CT, Mar 30th, 2011
Cara Banks $15M for Pursuit of Nonaddictive Pain Drug, by Donna Young (BioWorld Today), July 22, 2010
Cara Therapeutics Secures $15 Million Series D Financing to Continue Clinical Development of CR845, Shelton, CT, July 21, 2010
Cara's No-Brainer Opioid Solution, Shelton, CT, Feb 22nd, 2010
Cara Therapeutics Reports Positive Phase II Data for Novel Peripheral Analgesic In Acute Post-Operative Pain, San Carlos, CA, Feb 8th, 2010
Cara Therapeutics Initiates Phase II Proof-Of-Concept Trial of Novel Analgesic In Acute Post-Operative Pain, Shelton, CT, Jan 12th, 2009
Cara Therapeutics Announces Successful Completion of Phase I Clinical Trial of Novel Analgesic, CR845, Shelton, CT, August 5th, 2008
Cara Therapeutics Secures $12.3 Million In Series C Extension Financing, Shelton, CT, July 24th 2008
Cara Therapeutics Announces Issuance of U.S. Patent Covering Second Generation Kappa Opioid Receptor Agonists, Shelton, CT, July 22nd 2008
Cara Therapeutics Initiates Phase 1 Clinical Trial of Novel Analgesic, CR845, Shelton, CT (PRNewswire-FirstCall), April 28th, 2008
Cara Therapeutics Secures $19 Million In Series C Financing , Tarrytown, NY (PRNewswire-FirstCall), November 28th, 2006
Tripos and Cara Therapeutics Announce Medicinal Chemistry Partnership; Alliance to Address Unmet Medical Needs in the Treatment of Pain and Inflammation, ST. LOUIS & BUDE, England (BUSINESS WIRE), March 22nd, 2006
Cara Therapeutics Announces Results of Phase 1 Clinical Trial of Novel Analgesic, Tarrytown, NY, July 28th, 2005
Cara Therapeutics Initiates Clinical Trial of Novel Pain Drug Candidate, Tarrytown, NY, March 24th 2005
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Cara Therapeutics Initiates Phase II Trial of Novel Analgesic In Acute Post-Operative Pain Peripherally-Acting Kappa Opioid Agonist, CR845, to Be Studied in Both Pre- and Post-Operatove Drug Regimens Shelton, CT, August 3rd, 2011 /PRNewswire-FirstCall
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Cara Therapeutics, Inc. today announced the dosing of the first patient in a Phase II clinical trial of its peripherally-selective, kappa opioid agonist, CR845, for the treatment of acute post-operative pain. The double-blind, placebo-controlled trial is expected to enroll a minimum of 200 patients at multiple clinical sites in the United States, and will evaluate the efficacy and safety of intravenous CR845 administered both pre- and post-operatively in women undergoing laparoscopic hysterectomy. This trial follows the successful completion of a 46 patient, multi-center, double-blind Phase II study of CR845, in the same surgical population, where both analgesic and opioid-sparing effects of CR845 were demonstrated and the drug was found to be safe and well tolerated after a single post-operative dose.
“Initiation of this Phase II trial represents an important advancement in the clinical development of CR845 and will further our understanding of the optimal dosing regimen for the drug in the treatment of acute post-operative pain,” said James B. Jones, M.D. Pharm. D., Chief Medical Officer of Cara Therapeutics. “There remains a significant unmet need among surgical patients for an effective analgesic which greatly reduces the need for centrally-acting opioids and their associated adverse effects, such as nausea and vomiting. We believe that CR845 has the potential to become a new standard in the treatment of post-operative pain.”
"This trial is of particular importance as it will reinforce previous positive Phase II results for CR845 in a single-dose postoperative pain study," said Timothy Melson, M.D., study Principal Investigator, Anesthesiologist and pain management specialist, at Helen Keller Memorial Hospital in Sheffield, AL. "As a clinical investigator who has assessed the effects of many different analgesics in women undergoing hysterectomy, I am excited at the prospect of deploying this new class of drug that has been previously shown to substantially decrease the need for postoperative opioids, as well as greatly reduce the incidence of postoperative nausea & vomiting; two of the most troubling side effects experienced by patients using currently available analgesics. The goal of this study is to now find the most effective way to use CR845 in this patient population"
About CR845
CR845 is a highly selective, peripherally-restricted kappa opioid receptor agonist currently in development for the treatment of post-operative pain. In a randomized, placebo-controlled Phase II study, CR845 demonstrated evidence of analgesic efficacy when administered as a single intravenous dose to women following laparoscopic hysterectomy. In addition to decreases in reported pain levels, patients receiving CR845 required substantially lower amounts of post-operative opioids (narcotics) and showed a significant reduction in the incidence of post-operative nausea and vomiting. Cara recently completed a Phase 1b repeat dose safety study of intravenous CR845 and plans to complete a Phase 1 safety and pharmacokinetic study of an oral capsule formulation of CR845 later this year. More than 140 human subjects have been exposed to CR845 to date, with no cases of dysphoric reactions or hallucinations that are seen with centrally-acting kappa opioids.
About Cara Therapeutics
Cara Therapeutics is a privately held biotechnology company focused on developing novel, superior therapeutics to treat pain and inflammation associated with diverse medical conditions. Cara’s current pipeline includes near-term clinical drug candidates identified as mechanistically distinct, peripherally-acting analgesics.
Forward-Looking Statements
Certain statements in this press release are forward-looking statements that involve a number of risks and uncertainties. Such forward-looking statements include statements relating to the therapeutic applications of CR845 and about Cara’s strategy, technologies, pre-clinical and clinical programs, and ability to identify and develop drugs, as well as other statements that are not historical facts. Actual events or results may differ materially from Cara's expectations. Factors that could cause actual results to differ materially from the forward-looking statements may include, but are not limited to, the timing, success and cost of Cara's research and clinical studies and Cara's ability to obtain additional financing. These forward-looking statements represent Cara's judgment as of the date of this release. Cara disclaims any intent or obligation to update these forward-looking statements.
For more information, please contact: Derek Chalmers, President & CEO of Cara Therapeutics, Inc. +1-203-567-1500
Source: Cara Therapeutics, Inc.
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Cara Banks $15M for Pursuit of Nonaddictive Pain Drug
by Donna Young, July 22, 2010 /BioWorld Today
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The $15 million Series D financing Cara Therapeutics Inc. closed this week will go a long way toward advancing the development of its peripherally restricted kappa opioid agonist CR845, said CEO Derek Chalmers...
Read More... [PDF]
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Cara Therapeutics Secures $15 Million Series D Financing to Continue Clinical Development of CR845
Shelton, CT, July 21, 2010 /PRNewswire
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| CR845, a novel, peripherally restricted kappa opioid agonist, is currently in Phase 2 development for treatment of post-operative pain
Shelton, CT, July 21, 2010 /PRNewswire/ -- Cara Therapeutics, Inc. announced today that it had closed on a Series D financing of $15 million. The round was led by new investor, Rho Ventures, with participation from previous investors Alta Biopharma, Ascent Biomedical Ventures, CT Innovations, Devon Park BioVentures, Healthcare Private Equity, Mitsubishi International Corporation and MVM Life Science Partners. In conjunction with the financing, Martin Vogelbaum, a partner at Rho Ventures, will join Cara’s Board of Directors. The Series D financing will be used primarily for the continued clinical development of Cara’s lead peripherally restricted kappa opioid agonist, CR845, for the treatment of post-operative pain. Cara has raised more than $43M since inception.
“There has been little innovation in post-operative pain treatment where opioid use continues to be the standard of care even though it is associated with significant side effects which present an ongoing pharmacoeconomic burden for hospitals. Due to its peripheral activity and lack of CNS penetration, we believe Cara’s CR845 has a chance to provide opioid-like pain relief while significantly reducing opioid use and its associated side effects,” said Martin Vogelbaum, partner at Rho Ventures. “We have been impressed with the progress that the Cara team have made to date with CR845 and look forward to working with them as CR845 progresses through the clinic.”
“We are very pleased to welcome Rho Ventures as our newest investor and we look forward to benefiting from Martin’s considerable experience as we continue the clinical development of CR845”, said Derek Chalmers, President and CEO of Cara Therapeutics.
About CR845
CR845 is a highly selective, peripherally restricted kappa opioid receptor agonist currently in Phase 2 clinical development for the treatment of postoperative pain. Randomized, placebo-controlled Phase IIa studies have provided evidence of analgesic efficacy of CR845 administered as a single intravenous dose to women following laparoscopic hysterectomy. In addition to decreases in reported pain levels, patients receiving CR845 required substantially lower amounts of postoperative opioids for 16 hours, and showed a significant reduction in the incidence of postoperative nausea. Cara expects to complete a Phase 1b repeat dose safety study of CR845 by Q4 this year. Following this study, the company plans to conduct, a Phase 2b repeat dose efficacy study in laparoscopic hysterectomy patients. With a total of over 100 human subjects exposed to CR845 to date, there have been no cases of dysphoric reactions or hallucinations as seen previously with centrally-acting kappa opioids. .
About Cara Therapeutics
Cara Therapeutics is a privately held biotechnology company focused on developing novel, superior therapeutics to treat pain and inflammation associated with diverse medical conditions. In addition to CR845, Cara’s current pipeline includes near-term clinical development candidates within multiple proprietary classes of peripherally restricted cannabinoids with preclinical analgesic and anti-inflammatory activity. Cara also plans to develop entirely novel classes of analgesics that emerge from its proprietary GPCR DimerScreenTM technology
About Rho Ventures
Founded in 1981, Rho Ventures’ multi-stage investing strategy focuses on high-growth companies in large markets that disrupt traditional value chains. Rho Ventures’ investments span new media, healthcare, information technology and energy technology. The firm has offices in New York City, Palo Alto, Calif., and Montreal, and has more than $2 billion under management. For more information, visit www.rho.com.
Forward-Looking Statements
Certain statements in this press release are forward-looking statements that involve a number of risks and uncertainties. Such forward-looking statements include statements relating to the therapeutic applications of CR845 and about Cara’s strategy, technologies, pre-clinical and clinical programs, and ability to identify and develop drugs, as well as other statements that are not historical facts. Actual events or results may differ materially from Cara's expectations. Factors that could cause actual results to differ materially from the forward-looking statements include, but are not limited to, the timing, success and cost of Cara's research and clinical studies, and Cara's ability to obtain additional financing. These forward-looking statements represent Cara's judgment as of the date of this release. Cara disclaims any intent or obligation to update these forward-looking statements.
For more information, please contact: Derek Chalmers, President & CEO of Cara Therapeutics, +1-203-567-1500.
Source: Cara Therapeutics, Inc.
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Cara's No-Brainer Opioid Solution
San Carlos, CA, Feb 22nd, 2010 /The Bernstein Report on BioBusiness
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San Carlos, CA, Feb 22nd, 2010 /The Bernstein Report on BioBusiness/ -- Cara Therapeutics, Inc. believes its CR845 kappa opioid agonist will fare better than others because the peptide is too large to cross the blood-brain barrier, meaning it should avoid the side effects and narrow therapeutic windows associated with CNS receptor activation.
The company presented data from a Phase II trial to treat acute post-operative pain earlier this month, showing CR845 met the co-primary endpoint of pain reduction 48 hours after dosing...
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Cara Therapeutics Reports Positive Phase II Data for Novel Peripheral Analgesic In Acute Post-Operative Pain
Shelton, CT, Feb 8th, 2010 /PRNewswire-FirstCall
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Shelton, CT, Feb 8th, 2010 /PRNewswire-FirstCall/ -- Cara Therapeutics, Inc. today announced positive data in a Phase II proof-of-concept clinical trial of its peripherally-restricted kappa opioid agonist, CR845. The 46 patient Phase II, multi-center, double-blind, placebo-controlled study was conducted at eight hospitals in the United States and evaluated the efficacy and safety of CR845 in women following laparoscopic-assisted hysterectomy. Subjects were administered a single intravenous infusion of 0.040 mg/kg CR845 or placebo following surgery, upon reporting a moderate-to-severe pain intensity level of 5 to 8 on a 0-10 pain scale. Analgesia was first assessed by pain intensity measurements for up to 8 hours post-infusion or until the patient requested morphine by initiation of patient-controlled analgesia (PCA morphine). Subsequently, analgesia was assessed by the amount of morphine required to alleviate pain until 16 hrs after drug administration.
Significant pain relief was observed in CR845-treated patients over placebo from 4-8 hrs post-drug administration, as exemplified by a significant change in pain intensity difference (PID) scores (p<0.05). In addition, CR845-treated subjects required 32% less morphine than placebo-treated patients over the 16 hr post-drug administration (p<0.05). This morphine-sparing effect was accompanied by a substantial decrease in the incidence of undesirable side effects typically associated with morphine use, including an absence of vomiting and a 72% reduction in nausea (p<0.05) There was no evidence of centrally- mediated adverse effects or sedation after CR845 treatment.
Overall, these findings indicate that CR845 is safe and well-tolerated in these patients, with the potential to become a novel approach for the treatment of acute post-operative pain and nausea, thereby facilitating patient recovery and hospital discharge.
"These results are exciting for a number of reasons," said Raymond S. Sinatra, M.D., Ph.D., Professor of Anesthesiology and Co-Director, Acute Pain, at the Yale School of Medicine, "CR845 works selectively at the site of injury and not in the brain and so provides clinically effective pain relief without side effects such as nausea, vomiting, sedation and respiratory depression that are commonly observed with morphine and other narcotic analgesics. In addition, co-administration of CR845 significantly reduced the need for PCA morphine, to an extent comparable to that observed with injectable non-steroidal anti-inflammatory drugs or acetaminophen but without risk of bleeding, or hepato-renal toxicity."
"These data further extend our understanding of the exciting potential of CR845," said Derek Chalmers, Ph.D., D.Sc., President and Chief Executive Officer of Cara Therapeutics. "CR845 remains our lead product, and we look forward to concluding a development and marketing partnership as we continue to move the drug forward."
About CR845
CR845 is a potent and highly selective kappa opioid receptor agonist, currently in clinical development for the treatment of acute pain and pruritus (itch). CR845 was designed and selected for development based, in part, on its inaccessibility to the central nervous system (CNS), therefore precluding undesirable, CNS-mediated side effects. This peripherally-restricted kappa opioid receptor agonist has been shown to exhibit anti-nociceptive and anti-inflammatory activity in animal models of visceral, inflammatory, and neuropathic pain.
Clinical Phase 1 studies confirmed that within an active dose range, CR845 lacks mu opioid adverse effects, such as respiratory depression, as well as the CNS side effects of centrally-acting kappa opioids. Based on this safety profile, Cara Therapeutics is actively pursuing the clinical development of CR845 as an adjuvant for managing pain during the post-operative period to minimize the adverse effects of conventional analgesic medications. In addition, based on preclinical evidence of anti-itch activity, Cara Therapeutics is also pursuing the development of CR845 for alleviation of uremic pruritus in hemodialysis patients.
About Cara Therapeutics
Cara Therapeutics is a privately-held biotechnology company focused on developing novel, superior therapeutics to treat pain, inflammation, and itch associated with diverse medical conditions. In addition to CR845, Cara’s current pipeline includes near-term clinical drug candidates identified as mechanistically distinct, peripherally-acting analgesic, anti-inflammatory agents.
Forward-Looking Statements
Certain statements in this press release are forward-looking statements that involve a number of risks and uncertainties. Such forward-looking statements include statements relating to the therapeutic applications of CR845 and about Cara’s strategy, technologies, pre-clinical and clinical programs, and ability to identify and develop drugs, as well as other statements that are not historical facts. Actual events or results may differ materially from Cara's expectations. Factors that could cause actual results to differ materially from the forward-looking statements may include, but are not limited to, the timing, success and cost of Cara's research and clinical studies and Cara's ability to obtain additional financing. These forward-looking statements represent Cara's judgment as of the date of this release. Cara disclaims any intent or obligation to update these forward-looking statements.
For more information, please contact: Derek Chalmers, President & CEO of Cara Therapeutics, Inc. +1-203-567-1500
Source: Cara Therapeutics, Inc.
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Cara Therapeutics Initiates Phase II Proof-Of-Concept Trial of Novel Analgesic In Acute Post-Operative Pain
Shelton , CT , Jan 12th, 2009 /PRNewswire-FirstCall
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Shelton, CT, Jan 12th, 2009 /PRNewswire-FirstCall/ -- Cara Therapeutics, Inc. today announced that it is initiating a Phase II clinical trial of its long-acting peripheral kappa opioid agonist, CR845. The Phase II multi-center, double-blind, placebo-controlled trial will be conducted in the United States and will evaluate the analgesic efficacy and safety of intravenous CR845 during the post-operative period in women following laparoscopic-assisted hysterectomy. The trial is expected to enroll 120 patients, who will be randomly selected for treatment with one of two doses of CR845 or placebo. Results from the study are expected in the second half of 2009.
The Company also expects to initiate a Phase I study of an oral formulation of CR845 later in 2009.
About CR845
A previous Phase Ia single-center clinical trial of intravenous CR845 evaluated the safety, tolerability, pharmacokinetic profile, and pharmacological activity of the compound in a double-blind, randomized, placebo-controlled, single escalating intravenous dose study in 54 healthy male and female volunteers. CR845 was shown to be safe at all doses investigated, with no reports of serious side effects or adverse central nervous system activity. Linear, dose-proportional increases in systemic exposure to CR845 were observed. Low doses of CR845 stimulated physiological biomarkers of peripheral kappa opioid receptor activity, and also produced plasma levels of drug associated with analgesic efficacy in multiple preclinical studies.
In preclinical studies, CR845 was highly selective for the peripheral kappa opioid receptor. Animal studies indicate that CR845 is effective in treating pain of inflammatory, neuropathic and visceral origin and exhibited analgesic efficacy for up to 18 hours after a single dose. Analgesic activity was seen after intravenous, subcutaneous, or oral administration. Oral bioavailability was confirmed in multiple species. In contrast to currently marketed opioids, CR845 did not produce inhibition of intestinal transit (ileus) or elicit signs of abuse or addiction liability in animal models. Preclinical studies also indicate that CR845 possesses anti-itch activity.
About Cara Therapeutics
Cara Therapeutics is a privately held biotechnology company focused on developing novel, superior therapeutics to treat pain and inflammation associated with diverse medical conditions. Cara’s current pipeline includes near-term clinical drug candidates identified as mechanistically distinct, peripherally-acting analgesics.
Forward-Looking Statements
Certain statements in this press release are forward-looking statements that involve a number of risks and uncertainties. Such forward-looking statements include statements relating to the therapeutic applications of CR845 and about Cara’s strategy, technologies, pre-clinical and clinical programs, and ability to identify and develop drugs, as well as other statements that are not historical facts. Actual events or results may differ materially from Cara's expectations. Factors that could cause actual results to differ materially from the forward-looking statements may include, but are not limited to, the timing, success and cost of Cara's research and clinical studies and Cara's ability to obtain additional financing. These forward-looking statements represent Cara's judgment as of the date of this release. Cara disclaims any intent or obligation to update these forward-looking statements.
For more information, please contact: Derek Chalmers, President & CEO of Cara Therapeutics, Inc. +1-203-567-1500
Source: Cara Therapeutics, Inc.
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Cara Therapeutics Announces Successful Completion of Phase I Clinical Trial of Novel Analgesic, CR845
Shelton, CT, August 5th, 2008 /PRNewswire |
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Cara Therapeutics, Inc. today announced completion of a Phase I clinical trial for its second-generation, peripherally acting kappa opioid agonist, CR845, under development for the treatment of acute and chronic pain. The drug candidate was safe and well-tolerated after intravenous infusion, and resulted in plasma levels of CR845 expected to be associated with clinical analgesic activity. In addition, CR845 infusion triggered a quantitative endocrine biomarker of peripheral kappa opioid receptor activation at the lowest dose tested.
The Phase Ia single-center clinical trial evaluated the safety, tolerability, pharmacokinetic profile, and pharmacological activity of CR845 in a double-blind, randomized, placebo-controlled, single escalating intravenous dose study in 54 healthy male and female volunteers. CR845 was shown to be safe at all doses investigated, with no reports of serious side effects or adverse central nervous system activity. Linear, dose-proportional increases in systemic exposure to CR845 were observed. Low doses of CR845 resulted in plasma levels at or above the plasma levels of drug expected to be associated with clinical analgesic efficacy.
The Company plans to advance its intravenous formulation of CR845 into Phase II trials later in 2008. Based on the demonstrated safety, tolerability, and bioactivity of this formulation in Phase I, Cara will continue to develop its oral formulation of CR845 for advancement into Phase I.
About CR845
CR845 was designed to be highly selective for the peripheral kappa opioid receptor, with a prolonged duration of action relative to Cara’s first generation of peripheral kappa opioids. Animal studies indicate that CR845 is effective in reducing pain of inflammatory, neuropathic and visceral origin. The analgesic and anti-inflammatory effects of CR845 lasted for up to 18 hours after a single dose. CR845 was active after intravenous, subcutaneous, or oral administration. Preclinical studies also indicate that CR845 possesses anti-itch properties. Unlike currently marketed opioids, CR845 did not inhibit intestinal transit (ileus), impair breathing, or elicit signs of addiction in animal models. CR845 and related compounds are covered by a recently issued U.S. patent.
About Cara Therapeutics
Cara Therapeutics is a privately held biotechnology company focused on developing novel, superior therapeutics to treat pain and inflammation associated with diverse medical conditions. Cara’s current pipeline includes near-term clinical drug candidates within multiple classes of peripherally-acting analgesics. Cara also plans to develop entirely novel classes of analgesics that emerge from its proprietary GPCR DimerScreenTM technology.
Forward-Looking Statements
Certain statements in this press release are forward-looking statements that involve a number of risks and uncertainties. Such forward-looking statements include statements relating to the therapeutic applications of CR845 and about Cara’s strategy, technologies, pre-clinical and clinical programs, and ability to identify and develop drugs, as well as other statements that are not historical facts. Actual events or results may differ materially from Cara's expectations. Factors that could cause actual results to differ materially from the forward-looking statements include, but are not limited to, the timing, success and cost of Cara's research and clinical studies and Cara's ability to obtain additional financing. These forward-looking statements represent Cara's judgment as of the date of this release. Cara disclaims any intent or obligation to update these forward-looking statements.
For more information, please contact: Derek Chalmers, President & CEO of Cara Therapeutics, +1-203-567-1500
Source: Cara Therapeutics, Inc.
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Cara Therapeutics Secures $12.3 Million In Series C Extension Financing
Shelton, CT, July 24th, 2008 /PRNewswire-FirstCall |
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Cara Therapeutics, Inc. announced today that it had closed on $12.3 million of additional funding to its original $24 million Series C financing which was completed in 2007. The round was led by new investor, Devon Park Bioventures, and included participation by Connecticut Innovations. Previous investors participating in the round included; Ascent Biomedical Ventures, Mitsubishi International Corporation and Wistar Morris. In conjunction with the financing, Dr. Christopher Moller, General Partner at Devon Park Bioventures, will join Cara’s Board of Directors. The additional funds will be used primarily for further clinical development of both intravenous and oral formulations of Cara’s second generation peripherally-selective kappa opioid agonist, CR845.
About CR845
In preclinical studies, CR845 was highly selective for the peripheral kappa opioid receptor. Animal studies indicate that CR845 is effective in reducing pain of inflammatory, neuropathic and visceral origin. The analgesic and anti-inflammatory effects of CR845 lasted for up to 18 hours after a single dose. CR845 was active after intravenous, subcutaneous, or oral administration. Preclinical studies also indicate that CR845 possesses anti-itch properties. Unlike currently marketed opioids, CR845 did not inhibit intestinal transit (ileus), impair breathing or elicit signs of addiction in animal models. CR845 is currently completing Phase Ia studies.
About Cara Therapeutics
Cara Therapeutics is a privately held biotechnology company focused on developing novel, superior therapeutics to treat pain and inflammation associated with diverse medical conditions. Cara’s current pipeline includes near-term clinical drug candidates within multiple classes of peripherally-acting analgesics. Cara also plans to develop entirely novel classes of analgesics that emerge from its proprietary GPCR DimerScreenTM technology.
Forward-Looking Statements
Certain statements in this press release are forward-looking statements that involve a number of risks and uncertainties. Such forward-looking statements include statements relating to the therapeutic applications of CR845 and about Cara’s strategy, technologies, pre-clinical and clinical programs, and ability to identify and develop drugs, as well as other statements that are not historical facts. Actual events or results may differ materially from Cara's expectations. Factors that could cause actual results to differ materially from the forward-looking statements include, but are not limited to, the timing, success and cost of Cara's research and clinical studies and Cara's ability to obtain additional financing. These forward-looking statements represent Cara's judgment as of the date of this release. Cara disclaims any intent or obligation to update these forward-looking statements.
For more information, please contact: Derek Chalmers, President & CEO of Cara Therapeutics, +1-914-347-4040, Ext. 201.
Source: Cara Therapeutics, Inc.
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Cara Therapeutics Announces Issuance of U.S. Patent Covering Second Generation Kappa Opioid Receptor Agonists
Shelton, CT, July 22nd, 2008 /PRNewswire-FirstCall |
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Cara Therapeutics, Inc. announced today that The United States Patent and Trademark Office has issued U.S. Patent No. 7,402,564 entitled “Synthetic Peptide Amides” under its Accelerated Examination Program. The application was filed on November 12, 2007 and covers Cara’s second generation, peripherally-selective kappa opioid receptor agonist compounds. These compounds include CR845, currently completing a Phase I clinical trial and in development for injectable and oral delivery for the treatment of acute and chronic pain of visceral, inflammatory and neuropathic origin, and for the treatment of pruritis (itch), a common disorder associated with several diseases and conditions.
About CR845
In preclinical studies, CR845 was highly selective for the peripheral kappa opioid receptor. Animal studies indicate that CR845 is effective in treating pain of inflammatory, neuropathic and visceral origin and exhibits analgesic efficacy for up to 18 hours after a single dose. Analgesic activity was seen after intravenous, subcutaneous, or oral administration. Unlike currently marketed opioids, CR845 did not inhibit intestinal transit (ileus), impair breathing or elicit signs of addiction in animal models. Preclinical studies also indicate that CR845 possesses anti-itch activity. CR845 is currently completing Phase Ia studies.
About Cara Therapeutics
Cara Therapeutics is a privately held biotechnology company focused on developing novel, superior therapeutics to treat pain and inflammation associated with diverse medical conditions. Cara’s current pipeline includes near-term clinical drug candidates within multiple classes of peripherally-acting analgesics. Cara also plans to develop entirely novel classes of analgesics that emerge from its proprietary GPCR DimerScreenTM technology.
Forward-Looking Statements
Certain statements in this press release are forward-looking statements that involve a number of risks and uncertainties. Such forward-looking statements include statements relating to the therapeutic applications of Cara compounds and about Cara’s strategy, technologies, pre-clinical and clinical programs, and ability to identify and develop drugs, as well as other statements that are not historical facts. Actual events or results may differ materially from Cara's expectations. Factors that could cause actual results to differ materially from the forward-looking statements include, but are not limited to, the timing, success and cost of Cara's research and clinical studies and Cara's ability to obtain additional financing. These forward-looking statements represent Cara's judgment as of the date of this release. Cara disclaims any intent or obligation to update these forward-looking statements.
For more information, please contact: Derek Chalmers, President & CEO of Cara Therapeutics, +1-203-567-1501
Source: Cara Therapeutics, Inc.
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Cara Therapeutics Initiates Phase 1 Clinical Trial of Novel Analgesic, CR845
Shelton, CT, April 28th, 2008 /PRNewswire-FirstCall
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Cara Therapeutics, Inc. today announced that it has initiated a Phase 1 clinical trial of its long-acting peripheral kappa opioid receptor agonist, CR845. The Phase 1a single-center clinical trial will evaluate the safety, tolerability, pharmacokinetic profile, and pharmacological activity of CR845 in a double-blind, randomized, placebo-controlled, single escalating intravenous dose study in 58 healthy male and female volunteers.
The company is also developing oral and subcutaneous formulations of CR845.
About CR845
In preclinical studies, CR845 was highly selective for the peripheral kappa opioid receptor. Animal studies indicate that CR845 is effective in treating pain of inflammatory, neuropathic and visceral origin and exhibits analgesic efficacy for up to 18 hours after a single dose. Analgesic activity was seen after intravenous, subcutaneous, or oral administration. Unlike currently marketed opioids, CR845 did not inhibit intestinal transit (ileus) or elicit signs of addiction in animal models. Preclinical studies also indicate that CR845 possesses anti-itch activity.
About Cara Therapeutics
Cara Therapeutics is a privately held biotechnology company focused on developing novel, superior therapeutics to treat pain and inflammation associated with diverse medical conditions. Cara’s current pipeline includes near-term clinical drug candidates identified as mechanistically distinct, peripherally-acting analgesics.
Forward-Looking Statements
Certain statements in this press release are forward-looking statements that involve a number of risks and uncertainties. Such forward-looking statements include statements relating to the therapeutic applications of CR845 and about Cara’s strategy, technologies, pre-clinical and clinical programs, and ability to identify and develop drugs, as well as other statements that are not historical facts. Actual events or results may differ materially from Cara's expectations. Factors that could cause actual results to differ materially from the forward-looking statements include, but are not limited to, the timing, success and cost of Cara's research and clinical studies and Cara's ability to obtain additional financing. These forward-looking statements represent Cara's judgment as of the date of this release. Cara disclaims any intent or obligation to update these forward-looking statements.
For more information, please contact: Derek Chalmers CEO of Cara Therapeutics, Inc.,
+1-203-567-1501
Source: Cara Therapeutics, Inc.
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Cara Therapeutics Secures $19 Million In Series C Financing
Tarrytown, NY (PRNewswire-FirstCall), November 28th, 2006
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Cara Therapeutics, Inc. announced today that it had closed on $19 million of its Series C financing. New investors participating in the round include MVM Life Science Partners and Alta Biopharma Partners, as well as previous investors Ascent Biomedical Ventures. In conjunction with the financing, Dr. Stephen Reeders, Managing Partner of MVM Life Science Partners, and Ed Hurwitz, Director of Alta Partners, will join Cara’s Board of Directors.
“I am very pleased with the outstanding group of international investors we have attracted to participate in Cara’s Series C financing and look forward to working with them to advance our internal drug development pipeline”, said Dr. Derek Chalmers, President & CEO of Cara Therapeutics. “Combined with cash already on-hand, this financing provides Cara with operating capital through 2008 and provides the runway necessary to advance our next two drug candidates into the clinic”, he added.
Dr. Stephen Reeders commented “Over the last twenty years there has been little innovation in treating pain. There is a big gap in the choices available to clinicians between moderately efficacious OTC analgesics and centrally acting opiates with serious side effects. We believe that Cara Therapeutics is developing novel drugs to fill this gap.”
“We are extremely excited about Cara’s focus in pain and inflammation where major advances have been lacking for several decades,” commented Ed Hurwitz of Alta Partners. “The company’s truly differentiated kappa agonist, which is being tested in proof of concept studies, has the chance to substantially change the treatment options for acute and chronic pain sufferers. We found this opportunity along with the company’s rapidly advancing programs on exciting novel pain and inflammation targets to be a compelling investment opportunity,” added Hurwitz.
On January 5th of this year, Cara announced that it had entered into a worldwide licensing agreement with ALZA Corporation, a Johnson & Johnson company, for Cara’s novel peripherally-acting pain drug candidate, CR665. Under the terms of that agreement, Cara received an upfront payment and is eligible to receive pre-determined clinical and regulatory milestone payments. Cara is also eligible to receive royalties on sales of all marketed products incorporating the compound, as well as an option to co-promote intravenous products in the U.S.
About CR665
CR665 is the lead clinical development candidate from a series of highly selective peripheral kappa opioid receptor agonists. In preclinical studies, CR665 was highly selective for the peripheral kappa opioid receptor. Preclinical animal studies suggest that CR665 is a potent analgesic compound. In addition, unlike currently marketed opioids, CR665 does not produce inhibition of intestinal transit (ileus), induce respiratory depression, or elicit signs of euphoria or addiction in animal models. Preclinical studies also indicate that CR665 possesses anti-inflammatory activities.
A completed Phase 1a study of intravenous CR665 in healthy men and women indicated that the drug candidate was safe, well tolerated, and exhibited predictable pharmacokinetic characteristics. In addition, this study demonstrated plasma levels of CR665 associated with analgesic effects in preclinical studies, as well as biomarker evidence of peripheral kappa opioid receptor activation in both men and women.
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Tripos and Cara Therapeutics Announce Medicinal Chemistry Partnership; Alliance to Address Unmet Medical Needs in the Treatment of Pain and Inflammation
ST. LOUIS & BUDE, England (BUSINESS WIRE), March 22nd, 2006
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Tripos, Inc. (Nasdaq:TRPS), a leading provider of drug discovery chemistry and informatics products and services, today announced that Tripos Discovery Research Ltd. (TDR), based in Bude, England, has formed a new research collaboration with Cara Therapeutics, an emerging U.S. biotechnology company based in Tarrytown, N.Y. Cara is focused on developing novel therapeutics to treat medical conditions associated with pain and inflammation. Terms of the agreement were not disclosed.
A dedicated team of computational and medicinal chemists at TDR will work in partnership with Cara's project team to support its drug discovery programs. By combining Tripos' proprietary informatics tools with its expertise in medicinal chemistry, TDR's chemists will focus on the development of novel molecules for Cara's specific needs. Based on Tripos' contribution, these molecules have the potential to progress into full clinical development more quickly than current industry norms.
"I am confident in Tripos' capabilities to accelerate discovery programs," said Dr. Derek Chalmers, CEO and president of Cara Therapeutics. "Tripos' domain expertise in this therapeutic area complements our own, and we look forward to a fruitful partnership."
"We are delighted that Cara has selected Tripos Discovery Research to support its efforts to discover new medicines in the area of neuropathic pain," said Dr. Mark Allen, senior vice president and managing director of TDR. "The therapeutic options currently available to treat these debilitating conditions are very limited. This relationship, which leverages a component of our G-protein-coupled receptor (GPCR) LeadDiscovery(TM) library, underscores the high value attributed to our expertise and therapeutic medicinal chemistry capabilities."
General
This press release contains forward-looking statements concerning, among other things: (1) expectations regarding future revenues and earnings, resource allocation and capacity; (2) expectations regarding existing and future opportunities for drug discovery collaborations; and (3) expectations regarding the success of Tripos' LeadDiscovery program. These statements are based upon numerous assumptions which Tripos cannot control and involve risks and uncertainties that could cause actual results to differ. These statements should be understood in light of the risk factors set forth in the Company's filings with the Securities and Exchange Commission, including, without limitations those factors set forth in the Company's Form 10-K for the fiscal year ended Dec. 31, 2004, and from time to time in the Company's periodic filings with the Securities and Exchange Commission. Except as otherwise required under federal securities laws and the rules and regulations of the SEC, we do not have any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events, changes in assumptions or otherwise.
About Tripos, Inc.
Tripos (Nasdaq:TRPS) combines leading-edge technology and innovative science to deliver consistently superior chemistry-research products and services for the biotechnology, pharmaceutical and other life science industries. Within Tripos' Discovery Informatics (DI) business, the company provides software products and consulting services to develop, manage, analyze and share critical drug discovery information. Within Tripos' Discovery Research (DR) business, Tripos' medicinal chemists and research scientists partner directly with clients in their research initiatives, leveraging state-of-the-art information technologies and research facilities. Further information on Tripos can be found at http://www.tripos.com.
Tripos and the Tripos logo are registered trademarks of Tripos, Inc., and/or its affiliates in the United States and certain other countries.
All other trademarks mentioned in this document are the property of their respective owners.
CONTACT: Tripos, Inc.
Jim Rubin, 314-647-8837
or
Waggener Edstrom Worldwide
Bioscience and Healthcare Practice
Lisa Osborne, 202-326-0793 (Media only)
lisao@waggeneredstrom.com
SOURCE: Tripos, Inc.
Cara Therapeutics Announces Results of Phase 1 Clinical Trial of Novel Analgesic; CR665 Safe and Pharmacologically Active
Tarrytown, NY, July 28th, 2005 /PRNewswire-FirstCall/ |
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Cara Therapeutics, Inc. today announced results of a Phase 1 clinical trial for its peripherally acting kappa opioid agonist, CR665, under development
for the treatment of postoperative pain. The drug
candidate was safe and well-tolerated
after intravenous infusion, and resulted in plasma
levels of CR665 expected to be associated with clinical
analgesic activity. In addition,
CR665 infusion triggered a quantitative endocrine
biomarker of peripheral kappa opioid receptor activation in both men and women.
The Phase 1a single-center clinical trial evaluated the safety, tolerability,
pharmacokinetic profile, and pharmacological activity
of CR665 in a double-blind, randomized, placebo-controlled, single escalating
intravenous
dose study in 60 healthy male and female volunteers.
CR665 was shown to be safe at all doses investigated, with no apparent gender
differences,
and no reports of serious side effects or adverse
central nervous system activity. Linear, dose-proportional increases in systemic
exposure
to CR665 were observed. Relatively low doses of CR665
resulted in plasma levels at or above the plasma levels of a drug expected to be
associated
with clinical analgesic efficacy. In addition, the
pharmacological activity of CR665 at peripheral kappa receptors was
confirmed
utilizing
a quantitative endocrine biomarker, which demonstrated
receptor activation at relatively low doses of the drug candidate.
"We are extremely pleased with the outcome of our trial. These
preliminary results are consistent with CR665's peripheral mechanism
of action," stated Dr. Frédérique Menzaghi, Cara's
Vice President of Research and Development. “The results have
not only confirmed our expectations in relation to the safety of CR665
but have also provided evidence of kappa receptor activation at much
lower drug doses than predicted from preclinical animal studies.”
The Company aims to move CR665 forward into Phase 1b and Phase 2 trials
in the coming months.
About CR665
CR665 is the lead clinical development candidate from a series of highly
selective peripheral kappa opioid receptor agonists.
In preclinical studies, CR665 was highly selective for the peripheral
kappa opioid
receptor. Preclinical animal studies suggest that
CR665 is a potent analgesic compound. In addition, unlike currently
marketed opioids,
CR665 does not produce inhibition of intestinal transit
(ileus), induce respiratory depression, or elicit signs of addiction
in animal models.
Preclinical studies also indicate that CR665 possesses
anti-inflammatory activities.
About Cara Therapeutics
Cara Therapeutics is a privately held biotechnology company focused
on developing novel, superior therapeutics to treat pain and inflammation
associated with diverse medical conditions. Cara's current pipeline
includes near-term clinical drug candidates within a number of classes
of peripherally-acting analgesics.
Forward-Looking Statements
Certain statements in this press release are forward-looking
statements that involve a number of risks and uncertainties. Such forward-looking
statements include statements relating to the therapeutic applications
of CR665 and about Cara's strategy, technologies, pre-clinical and
clinical programs, and ability to identify and develop drugs, as well
as other statements that are not historical facts. Actual events or
results may differ materially from Cara's expectations. Factors that
could cause actual results to differ materially from the forward-looking
statements include, but are not limited to, the timing, success and
cost of Cara's research and clinical studies and Cara's ability to
obtain additional financing. These forward-looking statements represent
Cara's judgment as of the date of this release. Cara disclaims any
intent or obligation to update these forward-looking statements.
For more information, please contact:
Derek Chalmers
President & CEO
of Cara Therapeutics
+1-914-347-4040
Source: Cara Therapeutics, Inc.
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Cara Therapeutics Initiates Clinical Trial of
Novel Pain Drug Candidate
Tarrytown, NY, March 24th 2005 /PRNewswire/
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Cara
Therapeutics, Inc. announced today that it had initiated dosing in
a Phase 1 clinical
trial for CR665, its novel drug candidate for the
treatment of postoperative pain. The single-dose protocol is scheduled
to be completed in the
second quarter of 2005.
The study will evaluate the safety, tolerability and pharmacokinetic
profile of CR665 in a double-blinded, placebo-controlled, ascending
single intravenous dose, dose-escalation trial in healthy male and
female volunteers. The study is being conducted in the U.K.
"CR665 represents a very significant development opportunity in
the treatment of pain because of its unique mechanism of action," stated
Derek Chalmers, Cara's President and CEO. "By acting with unprecedented
selectivity at pain relieving receptors on peripheral nerves, and avoiding
receptors in the central nervous system and gastrointestinal tract,
CR665 has the potential to provide pain relief with minimal side effects.” Dr.
Chalmers added, “We believe that CR665's distinct mechanism could
not only provide great patient benefit compared to currently used drugs
for treating postoperative pain, but also result in significant reductions
in healthcare costs by minimizing hospitalization time.”
About CR665
CR665 is the lead development candidate from a series of highly selective peripheral
kappa opioid receptor
agonists.
In animal studies, CR665 exhibited unprecedented selectivity for the
peripheral kappa opioid
receptor and superior efficacy in producing pain
relief compared to non-selective opioid drugs, such as morphine. In
addition, unlike currently
marketed non-selective opioid receptor agonists,
CR665 does not produce inhibition of intestinal transit (ileus), induce
respiratory depression,
or elicit CNS side effects of euphoria or addiction
in animal models. In addition to its potent analgesic effects, preclinical
studies also
indicate that CR665 possesses anti-inflammatory activities
appropriate for potential therapeutic application in diseases such
as rheumatoid
arthritis.
About Cara Therapeutics
Cara Therapeutics is a privately held biotechnology company focused
on developing novel, superior therapeutics to treat pain and inflammation
associated with diverse medical conditions. Cara's current pipeline
includes near-term clinical drug candidates within a number of classes
of peripherally-acting analgesics.
Forward-Looking Statements
Certain statements in this press release are forward-looking statements
that involve a number of risks and uncertainties. Such forward-looking
statements include statements relating to the therapeutic applications
of CR665 and about Cara's strategy, technologies, pre-clinical and
clinical programs, and ability to identify and develop drugs, as well
as other statements that are not historical facts. Actual events or
results may differ materially from Cara's expectations. Factors that
could cause actual results to differ materially from the forward-looking
statements include, but are not limited to, the timing, success and
cost of Cara's research and clinical studies and Cara's ability to
obtain additional financing. These forward-looking statements represent
Cara's judgment as of the date of this release. Cara disclaims any
intent or obligation to update these forward-looking statements.
For more information, please contact:
Derek Chalmers
President & CEO
Cara Therapeutics
+1-914-347-4040
Source: Cara Therapeutics, Inc
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